A shortage in expertise is causing bottlenecks in the biomanufacturing space with around half of drugmakers struggling to fill processing positions, an industry report finds.
Novartis has scaled up manufacturing of wet age-related macular degeneration (AMD) monoclonal antibody RTH258 ahead of a potential regulatory submission next year.
Samsung Biologics wants Big Pharma to up biomanufacturing outsourcing and says lessons learned from the semiconductor industry will give it the advantage in the CMO space.
Shire will consolidate both R&D and biomanufacturing facilities in Massachusetts to establish a rare diseases hub in Cambridge and a ‘Technology Center of Excellence’ in Lexington.
CEO Ken Frazier has told investors investments and partnerships, such as collaboration with messenger RNA firm Moderna Therapeutics, have bolstered Merck & Co.’s vaccine division.
Its new Singapore single-use plant is a fraction of the size of a conventional commercial facility but next-generation biomanufacturing at Amgen points to even smaller, more integrated sites.
Novartis will add around 350 Swiss jobs to support its innovative biologics pipeline as it looks to cut 500 more “traditional” development and manufacturing roles.
A second single-use production line could offer commercial-scale capacity for bispecific antibodies but Glenmark says it would need to scale-up further to support more traditional biologics.
Vaxart says its tablet delivery platform has simplified vaccine production so significantly it may bring manufacturing currently contracted to Lonza back in-house.
The Chinese hamster ovary (CHO) cell line is not the future for biomanufacturing says Biogen, which will publish results from a study of alternative hosts later this year.
Sanofi Pasteur says heavy investment in messenger RNA (mRNA) is warranted as such technology could revolutionise vaccine development and manufacturing.
Abeona Therapeutics says it plans to file its single injection adeno-associated virus (AAV) gene therapy for Sanfilippo syndrome in the US in late 2018.
The only practical way to scale-up volumes of mesenchymal stem cells (MSCs) is by using microcarriers in single-use bioreactors, say scientists from A*STAR and Instituto Superior Técnico.
Xenetic Biosciences says success for Shire’s haemophilia A candidate SHP656 will validate its PolyXen drug delivery technology platform and could net the firm up to $100m.
Dispatches from the 1st Stem Cell Community Day, Hamburg
Process automation should be incorporated early when developing large scale cell therapy manufacturing platforms, according to a lead scientist from the UK Catapult.
Novartis and Kite Pharma have both submitted autologous leukemia candidates for review, paving the road for the first available chimeric antigen receptor (CAR) T cell therapy.
Plasticell has partnered with Singapore’s Agency for Science, Technology and Research (A*STAR) and the Nanyang Technological University (NTU) to advance its stem cell pipeline.
Hitachi Chemical Co. America will increase its presence in the cell therapy development and manufacturing space through the $75m acquisition of Caladrius Biosciences subsidiary PCT.
'One-litre bioreactor scale currently the maximal for stem cell expansion and differentiation'
Stem cell therapy developers are lacking production scale-up technologies, says the chair of an upcoming conference bringing industry and academia together to address the problem.
Humacyte has received one of the first US FDA regenerative medicine designations for its investigational human acellular vessels (HAVs) candidate Humacyl.
The investment at the Gödöllö manufacturing site adds 104 jobs and comes a week before GSK breaks ground on a $170m meningitis B vaccine facility in Germany.
Two Bill & Melinda Gates Foundation grants will be used to develop a polio and measles rubella vaccine delivered through microneedles on a sustained-dermal patch.
Contract research organisation (CRO) ICON has taken a hit to its book-to-bill ratio after Pfizer dropped its anti-cholesterol candidate bococizumab in November.
CMOs will struggle to compete with large in-house capacity investments, according to Results Healthcare which predicts a decline in outsourced biomanufacturing.
Rumours of an Irish expansion freeze have been greatly exaggerated according to Eli Lilly, which says it remains committed to its Kinsale biomanufacturing site.
Amsterdam-based Kiadis Biopharma has received Health Canada approval to initiate a global Phase III trial for an allogenic stem cell therapy for acute leukemia.
Drugmakers have been invited to submit preliminary clinical evidence for cell and gene therapies under the new US FDA Regenerative Advanced Therapy designation
Kite Pharma has formed a joint venture with Shanghai Fosun Pharmaceutical Industrial Development Company to develop and manufacture its cell therapy axicabtagene ciloleucel in the Chinese market.
The development partnership has been extended as GlaxoSmithKline looks to make clinical trial scale batches using Puridify’s Protein A alternative to packed bed chromatography columns.
An automated system co-developed with Cook Regenetec offers a more controlled and repeatable method of thawing cell and gene therapies than traditional techniques, says Asymptote.
